Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults (D1AMOND)

April 16, 2024 updated by: Emalex Biosciences Inc.

A Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Safety and Maintenance of Efficacy of Ecopipam in Children, Adolescents and Adults With Tourette's Disorder

This Phase 3 multicenter study evaluates the maintenance of efficacy, safety and tolerability of ecopipam tablets in children, adolescents and adults in the treatment of Tourette's Disorder (TD). The study includes an open-label period followed by double-blind, placebo-controlled, randomized withdrawal period.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Following a 28-day Screening period and Baseline visit, eligible subjects will be enrolled into the open-label Stabilization period comprised of a 4-week Titration phase to achieve a target steady-state dose of 1.8 mg/kg/day ecopipam (2 mg/kg/day ecopipam HCl) followed by an 8-week open-label Maintenance phase. Responders to ecopipam will be randomized to ecopipam 1.8 mg/kg/day (2 mg/kg/day ecopipam HCl) or placebo in a 1:1 fashion and enter the double-blind Randomized-Withdrawal (R/WD) period at Week 12. During the 12-week R/WD period, any subject meeting Relapse criteria will be withdrawn from blinded study medication and complete end of study assessments including safety follow up visits.

Study Type

Interventional

Enrollment (Estimated)

196

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Bulgaria
      • Plovdiv, Bulgaria, 4004
        • Recruiting
        • Center Spectar-Plovdiv
        • Contact:
      • Sofia, Bulgaria, 1680
        • Recruiting
        • Kalimat Medical Center_Sofia
        • Contact:
      • Varna, Bulgaria, 9020
        • Recruiting
        • DCC Mladost-M Varna
        • Contact:
          • Petar Petrov, MD
          • Phone Number: 359888940142
          • Email: pmdown@abv.bg
    • Lyulin 1
      • Sofia, Lyulin 1, Bulgaria, 1360
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Recruiting
        • University of Calgary
        • Contact:
    • Ontario
      • Ajax, Ontario, Canada, L1Z 0M1
        • Recruiting
        • The Kids Clinic Inc
        • Contact:
      • Ottawa, Ontario, Canada, K2G 1W2
        • Not yet recruiting
        • Center for Pediatric Excellence
        • Contact:
          • van Stralen Judy, MD
          • Phone Number: 613 726-7436
          • Email: judy@cfpe.ca
  • Denmark
  • France
  • Germany
      • Mannheim, Germany, 68159
        • Recruiting
        • Zentralinstitut fuer Seelische Gesundheit, Mannheim
        • Contact:
    • Bayern
      • Muenchen, Bayern, Germany, 80336
        • Recruiting
        • Psychiatric Clinic of Ludwig Maximilians Universitaet Muenchen
        • Contact:
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • Recruiting
        • Department of Psychiatry, Socialpsychiatry and Psychotherapy, Hannover Medical School
        • Contact:
  • Hungary
      • Budapest, Hungary, 1021
        • Recruiting
        • Vadaskert Gyermek- es Ifjusagpszichiatriai Korhaz es Szakambulancia
        • Contact:
      • Budapest, Hungary, 1146
        • Recruiting
        • Bethesda Childrens Hospital(Magyarországi Református Egyház Bethesda Gyermekkórháza)
        • Contact:
    • Csongrád
      • Szeged, Csongrád, Hungary, 6725
        • Recruiting
        • Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Gyermek
        • Contact:
  • Italy
      • Catania, Italy, 95123
        • Recruiting
        • Azienda Ospedaliera Vittorio Emanuele Policlinico // Azienda Ospedaliera Policlinico San Marco
        • Contact:
      • Genova, Italy, 16148
        • Recruiting
        • Ospedale Pediatrico Istituto Giannina Gaslini di Genova
        • Contact:
      • Milano, Italy, 20133
      • Napoli, Italy, 80131
        • Recruiting
        • Università Degli Studi Di Napoli Federico Ii
        • Contact:
    • LC
      • Bosisio Parini, LC, Italy, 23842
        • Recruiting
        • Istituto Di Ricovero E Cura A Carattere Scientifico IRCCS Eugenio Medea
        • Contact:
  • Poland
      • Krakow, Poland, 30-363
        • Recruiting
        • Centrum Medyczne Plejady
        • Contact:
    • Pomorskie
      • Gdańsk, Pomorskie, Poland, 80-542
        • Recruiting
        • Gdanskie Centrum Zdrowia Sp z o.o.
        • Contact:
    • Silesia
      • Katowice, Silesia, Poland, 42-123
        • Recruiting
        • Wielospecjalistyczna Poradnia Lekarska Synapsis
        • Contact:
    • Woj. Malopolskie
      • Krakow, Woj. Malopolskie, Poland, 31-503
        • Recruiting
        • Wojewdzki Specjalistyczny Szpital Dziecicy im. sw. Ludwika w Krakowie
        • Contact:
  • Romania
      • Dorobanti, Romania, 41914
        • Recruiting
        • Spitalul Clinic de Psihiatrie Prof Dr Al. Obregia Bucureti
        • Contact:
  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • Clinic of Neurology and Psychiatry for Children and Adolescents
        • Contact:
      • Nis, Serbia, 18000
        • Recruiting
        • Clinical Centre Nis Center of Mental Health
        • Contact:
      • Novi Sad, Serbia, 21000
        • Recruiting
        • Clinical Center Vojvodina
        • Contact:
    • Belgrad
      • Belgrade, Belgrad, Serbia, 11120
        • Recruiting
        • Institute of Mental Health
        • Contact:
  • Spain
      • Barcelona, Spain, 8036
        • Recruiting
        • Hospital Clínic de Barcelona
        • Contact:
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de octubre
        • Contact:
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Maranon
        • Contact:
          • Maria Concepcion Miranda Herrero, MD
          • Phone Number: 0034 915290243
          • Email: mconchi82@yahoo.es
      • Sevilla, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena Unidad de Investigacion Neurologia
        • Contact:
      • Sevilla, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocío, C/Antonio Maura Montaner, s/n, edificio IBiS
        • Contact:
          • Pablo Mir Rivera
          • Phone Number: 0034-955923039
          • Email: pmir@us.es
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Recruiting
        • Hospital Universitario Central de Asturias
        • Contact:
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36303
        • Recruiting
        • Harmonex Neuroscience Research
        • Contact:
    • Arizona
      • Phoenix, Arizona, United States, 85016
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Recruiting
        • Arkansas Children's Hospital
        • Contact:
    • California
      • Anaheim, California, United States, 92805
        • Recruiting
        • Advanced Research Center
        • Contact:
      • Bellflower, California, United States, 90706
        • Recruiting
        • CenExel CIT-IE
        • Contact:
      • Glendale, California, United States, 91203
        • Recruiting
        • Cortica Site Network
        • Contact:
      • Irvine, California, United States, 92604
      • San Rafael, California, United States, 94903
        • Recruiting
        • Cortica Site Network - San Rafael
        • Contact:
      • Santa Ana, California, United States, 92705
        • Recruiting
        • Syrentis Clinical Research
        • Contact:
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Recruiting
        • Yale School of Medicine
        • Contact:
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • Florida
      • Gainesville, Florida, United States, 32608
      • Gulf Breeze, Florida, United States, 32561
        • Recruiting
        • NW FL Clinical Research Group, LLC
        • Contact:
      • Hialeah, Florida, United States, 33013-3834
      • Hollywood, Florida, United States, 33024
        • Not yet recruiting
        • Med Research Associates, Inc
        • Contact:
      • Jensen Beach, Florida, United States, 34957
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Miller School of Medicine
        • Contact:
      • Miami, Florida, United States, 33173
        • Recruiting
        • Florida International Research Center
        • Contact:
      • Miami, Florida, United States, 33144
        • Not yet recruiting
        • IM Medical Research Center LLC
        • Contact:
      • Orange City, Florida, United States, 32763
        • Recruiting
        • Medical Research Group of Central Florida
        • Contact:
      • Orlando, Florida, United States, 32803
        • Recruiting
        • APG Research LLC
        • Contact:
      • Saint Petersburg, Florida, United States, 33701
        • Recruiting
        • University of South Florida
        • Contact:
      • Tampa, Florida, United States, 33609-4181
        • Recruiting
        • Pediatric Epilepsy and Neurology Specialists
        • Contact:
      • Tampa, Florida, United States, 33617
        • Not yet recruiting
        • Jedidiah Clinical Research
        • Contact:
      • Winter Park, Florida, United States, 32789
    • Georgia
    • Illinois
      • Chicago, Illinois, United States, 60634
      • Chicago, Illinois, United States, 60637-1447
        • Recruiting
        • The University of Chicago Hospitals
        • Contact:
      • Chicago, Illinois, United States, 60611
        • Not yet recruiting
        • Lurie Children Hospital of Chicago
        • Contact:
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • 1725 W. Harrison St., Suite 755
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Recruiting
        • Josephson-Wallack-Munshower Neurology
        • Contact:
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Not yet recruiting
        • University of Louisville Research Foundation Inc.
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Not yet recruiting
        • Kennedy Krieger Institute
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
      • Worcester, Massachusetts, United States, 01655
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Recruiting
        • Michigan Clinical Research Institute PC
        • Contact:
          • Rajaprabhakaran Rajarethinam, MD
          • Phone Number: 734-834-8954
          • Email: rpmmc@yahoo.com
      • Bloomfield Hills, Michigan, United States, 48302-1952
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Not yet recruiting
        • The Childrens Mercy Hospital
        • Contact:
      • Saint Charles, Missouri, United States, 63304
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Contact:
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Recruiting
        • Alivation Research
        • Contact:
    • New York
      • New York, New York, United States, 10029-6504
        • Recruiting
        • Mount Sinai School of Medicine
        • Contact:
          • Robert Jaffe, MD
      • New York, New York, United States, 10016-5815
      • Rochester, New York, United States, 14642
      • Stony Brook, New York, United States, 11794
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
      • Winston-Salem, North Carolina, United States, 27157-0001
        • Recruiting
        • Wake Forest Baptist Medical Center - PPDS
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45229-3026
        • Recruiting
        • Cincinnati Childrens Hospital Medical Center
        • Contact:
      • Columbus, Ohio, United States, 43205
      • Middleburg Heights, Ohio, United States, 44130
    • Oregon
      • Portland, Oregon, United States, 97225
        • Not yet recruiting
        • Providence Brain and Spine Institute
        • Contact:
    • Pennsylvania
      • Media, Pennsylvania, United States, 19063
    • South Carolina
      • Charleston, South Carolina, United States, 29414
    • Tennessee
      • Nashville, Tennessee, United States, 37232-7610
      • Nashville, Tennessee, United States, 37203-6502
    • Texas
      • Dallas, Texas, United States, 75390
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas Health Science Center at Houston
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Children's Hospital (TCH)
        • Contact:
      • San Antonio, Texas, United States, 78249-3539
    • Utah
      • Draper, Utah, United States, 84020
    • Washington
      • Everett, Washington, United States, 98201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ≥ 6 years of age
  • ≥ 18 kg (~ 40 lbs.)
  • TD diagnosis and both motor and vocal tics that cause impairment with normal routines
  • Minimum score of 20 on the YGTSS-R Total Tic Score
  • May not be taking any medications used to treat motor or vocal tics for at least 14 days prior to Baseline.
  • Effective contraception during the study and 30 days after last study dose for sexually active subjects

Exclusion Criteria:

  • Previous exposure to ecopipam
  • Certain mood or psychiatric disorders (i.e., dementia, bipolar disorder, schizophrenia, major depressive disorder)
  • Unstable unstable medical illness or clinically significant lab abnormalities
  • Risk of suicide
  • Pregnant or lactating women
  • Moderate to severe renal insufficiency
  • Hepatic insufficiency
  • Positive urine drug screen
  • Unstable doses for drugs to treat anxiety, depression, Attention Deficit Hyperactivity Disorder
  • Certain medications that would lead to drug interactions
  • Recent behavioral therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1.8 mg/kg/day ecopipam (2 mg/kg/day ecopipam HCl)
Ecopipam 11.2, 22.4, 33.6, 44.8, 67.2 and 89.6 mg tablets (containing 12.5, 25, 37.5, 50, 75 and 100 mg ecopipam HCl, respectively); 1.8 mg/kg/day ecopipam (2 mg/kg/day ecopipam HCl) target dose; oral administration daily in evenings.
Drug: Ecopipam Hydrochloride
Selective dopamine D1 and D5 receptor antagonist
Placebo Comparator: Placebo during R/WD Phase
Matching Placebo tablets during R/WD period taken orally in the evening.
Drug: Ecopipam Hydrochloride
Selective dopamine D1 and D5 receptor antagonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Yale Global Tic Severity Scale (YGTSS)
Time Frame: Screening up to Week 24
Clinician-completed rating scale with score ranging from 0 to 50 (0=none to 50=severe)
Screening up to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emalex Biosciences Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

November 7, 2022

First Submitted That Met QC Criteria

November 7, 2022

First Posted (Actual)

November 14, 2022

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EBS-101-TD-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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